SUPPLY CHAIN ARTICLES
-
The Expanding Patent Landscape For RNA-Based Therapeutics
The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
-
ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
-
Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault
What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
-
Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned
One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.
-
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
-
Therapeutic Oligonucleotides: Regulations & Quality Standards
Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
-
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
-
Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.
-
Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
-
Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
-
Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
-
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.